Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,149
- 试验地点
- 1
- 主要终点
- sensitivity of the fecal immunochemical test for the detection of colorectal cancers
研究概览
简要总结
Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.
详细描述
Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic accuracy for CRCs than previous screening tests. Determining the incidence of post-test interval CRCs, diagnosed after a negative FIT and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. The primary objective of this study was to evaluate the performance of FIT during the CRC screening campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (IC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects between 50 and 77 years diagnosed with an in situ or an invasive CRC
- •Inhabitants of the Finistère area
- •Subjects were included by period:
- •from January 2016 to December 2017 for subjects with SD-CRC, non-responders and the excluded population
- •from January 2016 to December 2019 for subjects with FIT-ICs (2-year interval)
- •from January 2016 to December 2020 for subjects with post-colonoscopy IC
- •from January 2018 to December 2020 for subjects with delayed diagnosis
排除标准
- •Subjects who refused to participate in the case of refusal of data collection
- •Subject swith CRC other than adenocarcinoma were excluded.
结局指标
主要结局
sensitivity of the fecal immunochemical test for the detection of colorectal cancers
时间窗: We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Sensitivity = True positive / True positive + False negative = SD CRCs / SD CRCs + FIT IC
次要结局
- Survival(We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.)
- Treatment(We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.)
- Parameters affecting the sensitivity of FIT, risk factors of interval cancer(We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.)
- FIT value(FIT data included its value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),)